妥布霉素
药代动力学
雾化器
耐受性
吸入器
医学
吸入
痰
囊性纤维化
药理学
麻醉
抗生素
不利影响
化学
内科学
哮喘
病理
庆大霉素
肺结核
生物化学
作者
Matthias Griese,Claudia Eismann,G. Börner,Oliver Denk,Jörg Michael Schierholz,Manfred Keller,Henryk Mazurek,Matthias Kappler
出处
期刊:Journal of Aerosol Medicine and Pulmonary Drug Delivery
[Mary Ann Liebert]
日期:2014-06-01
卷期号:27 (3): 185-192
被引量:9
标识
DOI:10.1089/jamp.2012.1022
摘要
Background: Improved inhalation device/drug combinations are necessary to advance inhaled antibiotic therapy in cystic fibrosis (CF). Previously, for a novel drug/inhaler combination, equivalent lung deposition was demonstrated; here, we investigated its safety and pharmacokinetics. Methods: In a randomized, open-labeled, multicenter, active controlled, parallel 28-day study, we compared a new tobramycin formulation (T100 PARI, 150 mg/1.5 mL) nebulized with a drug-specific PARI eFlow® nebulizer and TOBI® (300 mg/5 mL) nebulized with a PARI LC PLUS® nebulizer in 78 CF patients. Results: Noninferiority of the primary endpoint peak plasma tobramycin concentrations and the secondary endpoint area under the concentration time curves in plasma were observed. Sputum concentrations exceeded expected minimum inhibitory concentrations of Pseudomonas aeruginosa and were the same across both treatment groups, as were tolerability and safety. The nebulization time (4.6 vs. 16.1 min) was much shorter for the new drug/device combination. Conclusion: Inhaled therapy with T100 PARI delivered by an investigational eFlow offers a patient treatment time benefit and comparable safety and pharmacokinetics.
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